CA2918852A1 - Composition pharmaceutique contenant du dimethyl fumarate pour l'administration a une faible dose quotidienne - Google Patents

Composition pharmaceutique contenant du dimethyl fumarate pour l'administration a une faible dose quotidienne Download PDF

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Publication number
CA2918852A1
CA2918852A1 CA2918852A CA2918852A CA2918852A1 CA 2918852 A1 CA2918852 A1 CA 2918852A1 CA 2918852 A CA2918852 A CA 2918852A CA 2918852 A CA2918852 A CA 2918852A CA 2918852 A1 CA2918852 A1 CA 2918852A1
Authority
CA
Canada
Prior art keywords
weight
pharmaceutical composition
dimethyl fumarate
composition according
lactose
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA2918852A
Other languages
English (en)
Inventor
Christin Galetzka
Chris Rundfeldt
Roland Rupp
Peder M. Andersen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
FWP IP ApS
Original Assignee
Forward Pharma AS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Forward Pharma AS filed Critical Forward Pharma AS
Publication of CA2918852A1 publication Critical patent/CA2918852A1/fr
Abandoned legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/225—Polycarboxylic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention concerne des compositions pharmaceutiques contenant du diméthyl fumarate (DMF). Plus spécifiquement, la présente invention concerne une composition pharmaceutique pour une utilisation orale dans le traitement du psoriasis par administration d'une faible dose quotidienne dans la plage de 375 mg ± 5 % de diméthyl fumarate, la formulation pharmaceutique se trouvant sous la forme d'un comprimé à matrice d'érosion.
CA2918852A 2013-08-26 2014-08-26 Composition pharmaceutique contenant du dimethyl fumarate pour l'administration a une faible dose quotidienne Abandoned CA2918852A1 (fr)

Applications Claiming Priority (13)

Application Number Priority Date Filing Date Title
US201361870096P 2013-08-26 2013-08-26
EP13181735 2013-08-26
EP13181735.5 2013-08-26
US61/870,096 2013-08-26
US201361895740P 2013-10-25 2013-10-25
EP13190304 2013-10-25
EP13190304.9 2013-10-25
US61/895,740 2013-10-25
US201462035898P 2014-08-11 2014-08-11
US62/035,898 2014-08-11
EP14180569 2014-08-11
EP14180569.7 2014-08-11
PCT/EP2014/068095 WO2015028473A1 (fr) 2013-08-26 2014-08-26 Composition pharmaceutique contenant du diméthyl fumarate pour l'administration à une faible dose quotidienne

Publications (1)

Publication Number Publication Date
CA2918852A1 true CA2918852A1 (fr) 2015-03-05

Family

ID=52585633

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2918852A Abandoned CA2918852A1 (fr) 2013-08-26 2014-08-26 Composition pharmaceutique contenant du dimethyl fumarate pour l'administration a une faible dose quotidienne
CA2918846A Abandoned CA2918846A1 (fr) 2013-08-26 2014-08-26 Composition pharmaceutique contenant du fumarate de dimethyle pour une administration a une faible dose journaliere

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA2918846A Abandoned CA2918846A1 (fr) 2013-08-26 2014-08-26 Composition pharmaceutique contenant du fumarate de dimethyle pour une administration a une faible dose journaliere

Country Status (9)

Country Link
US (11) US20160206586A1 (fr)
EP (4) EP3517102A1 (fr)
JP (2) JP2016528302A (fr)
KR (4) KR20160046813A (fr)
CN (4) CN105658207A (fr)
AU (6) AU2014314231A1 (fr)
CA (2) CA2918852A1 (fr)
EA (2) EA201690107A1 (fr)
WO (2) WO2015028472A1 (fr)

Families Citing this family (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK2334378T3 (da) 2008-08-19 2014-07-07 Xenoport Inc Prodrugs af methylhydrogenfumarat, farmaceutiske sammensætninger deraf og fremgangsmåder til anvendelse
AU2013305684B2 (en) 2012-08-22 2016-11-24 Xenoport, Inc. Oral dosage forms of methyl hydrogen fumarate and prodrugs thereof
US10945984B2 (en) 2012-08-22 2021-03-16 Arbor Pharmaceuticals, Llc Methods of administering monomethyl fumarate and prodrugs thereof having reduced side effects
WO2014160633A1 (fr) 2013-03-24 2014-10-02 Xenoport, Inc. Compositions pharmaceutiques de fumarate de diméthyle
US9302977B2 (en) 2013-06-07 2016-04-05 Xenoport, Inc. Method of making monomethyl fumarate
WO2014205392A1 (fr) 2013-06-21 2014-12-24 Xenoport, Inc. Co-cristaux de diméthyl fumarate
TW201516020A (zh) 2013-09-06 2015-05-01 Xenoport Inc （ｎ，ｎ－二乙基胺甲醯基）甲基（２ｅ）丁－２－烯－１，４－二酸甲酯之晶形、合成方法及用途
WO2015044853A2 (fr) * 2013-09-25 2015-04-02 Glenmark Pharmaceuticals Limited; Glenmark Generics Limited Procédé de préparation de fumarate de diméthyle
DK3110408T3 (en) 2014-02-28 2019-04-29 Banner Life Sciences Llc ENTERY SOFT CAPS OF CONTROLLED RELEASE FUMAR TESTERS
US10098863B2 (en) 2014-02-28 2018-10-16 Banner Life Sciences Llc Fumarate esters
US9636318B2 (en) 2015-08-31 2017-05-02 Banner Life Sciences Llc Fumarate ester dosage forms
US9326947B1 (en) 2014-02-28 2016-05-03 Banner Life Sciences Llc Controlled release fumarate esters
US9999672B2 (en) 2014-03-24 2018-06-19 Xenoport, Inc. Pharmaceutical compositions of fumaric acid esters
AU2016273068A1 (en) 2015-06-01 2017-12-21 Sun Pharmaceutical Industries Ltd. Pharmaceutical compositions of dimethyl fumarate
WO2017040272A1 (fr) * 2015-08-31 2017-03-09 Banner Life Sciences Llc Formes posologiques d'ester de fumarate
EA201800403A1 (ru) * 2015-12-31 2018-12-28 Заклады Фармацеутицне Польфарма С.А. Способ получения покрытого кишечнорастворимой оболочкой гранулята, содержащего диметилфумарат
KR101800956B1 (ko) * 2016-04-04 2018-01-25 주식회사 와이제이테크 파이토스핑고신과 효모추출물을 유효성분으로 포함하는 탈모방지 및 발모촉진용 조성물
RU2616605C1 (ru) * 2016-04-07 2017-04-18 Олег Ростиславович Михайлов Кристаллическая бета - модификация (Е)-диметилбутендиоата, способ её получения и фармацевтическая композиция на её основе
GR1009149B (el) * 2016-10-25 2017-10-31 Φαρματεν Αβεε Φαρμακευτικα σκευασματα που περιλαμβανουν εναν εστερα φουμαρικου οξεως και μεθοδος παραγωγης αυτων
WO2020106330A1 (fr) * 2018-07-18 2020-05-28 Pillsy, Inc. Dispositif intelligent d'administration et de surveillance de médicament, kit et procédé d'utilisation pour des composés de pilules
WO2020053218A1 (fr) * 2018-09-13 2020-03-19 Almirall, S.A. Traitement du psoriasis
TR201818859A2 (tr) * 2018-12-07 2020-06-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Di̇meti̇l fumarat ve en az bi̇r kas gevşeti̇ci̇ ajan i̇çeren bi̇r kombi̇nasyon
US20220087942A1 (en) * 2019-05-31 2022-03-24 Curacle Co., Ltd. Enteric tablet containing dimethyl fumarate
US11903918B2 (en) 2020-01-10 2024-02-20 Banner Life Sciences Llc Fumarate ester dosage forms with enhanced gastrointestinal tolerability
WO2022212893A1 (fr) * 2021-04-02 2022-10-06 Biogen Ma Inc. Méthodes de traitement combiné de la sclérose en plaques

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19814358C2 (de) 1998-03-31 2002-01-17 Fumapharm Ag Muri Verwendung von Alkylhydrogenfumaraten zur Behandlung von Psoriasis, psoriatischer Arthritis, Neurodermitis und Enteritis regionalis Crohn
DE19848260C2 (de) 1998-10-20 2002-01-17 Fumapharm Ag Muri Fumarsäure-Mikrotabletten
DE19853487A1 (de) 1998-11-19 2000-05-25 Fumapharm Ag Muri Verwendung von Dialkylfumaraten
DE14172398T1 (de) * 2004-10-08 2015-01-08 Forward Pharma A/S Gesteuerte Freisetzung von pharmazeutischen Zusammensetzungen mit Fumarinsäureester
CN101304732A (zh) * 2005-10-07 2008-11-12 Adi技术制药股份公司 包含富马酸酯的控释药物组合物
WO2007042034A1 (fr) * 2005-10-07 2007-04-19 Aditech Pharma Ab Compositions pharmaceutiques a liberation controlee comportant un ester de l'acide fumarique
PT2564839T (pt) * 2009-01-09 2016-07-14 Forward Pharma As Formulação farmacêutica compreendendo um ou mais ésteres de ácido fumárico numa matriz de erosão
WO2010079221A1 (fr) * 2009-01-09 2010-07-15 Forward Pharma A/S Composition pharmaceutique comprenant un ou plusieurs esters d'acide fumarique

Also Published As

Publication number Publication date
AU2019268049B2 (en) 2021-08-26
CN109453133A (zh) 2019-03-12
US20180338946A1 (en) 2018-11-29
US20160206587A1 (en) 2016-07-21
US20190201369A1 (en) 2019-07-04
AU2014314230A1 (en) 2016-04-07
KR20210147082A (ko) 2021-12-06
CN105682648A (zh) 2016-06-15
CN109223725A (zh) 2019-01-18
US20160206586A1 (en) 2016-07-21
KR20210139485A (ko) 2021-11-22
CA2918846A1 (fr) 2015-03-05
EA201690102A1 (ru) 2016-06-30
KR20160046813A (ko) 2016-04-29
AU2021215272A1 (en) 2021-09-02
EP3492072A1 (fr) 2019-06-05
CN105658207A (zh) 2016-06-08
EP3038605A1 (fr) 2016-07-06
JP2016531912A (ja) 2016-10-13
US20170231943A1 (en) 2017-08-17
US20210290582A1 (en) 2021-09-23
AU2021269434A1 (en) 2021-12-16
AU2019268052A1 (en) 2019-12-05
US20180021289A1 (en) 2018-01-25
EA201690107A1 (ru) 2016-10-31
KR20160045728A (ko) 2016-04-27
WO2015028472A1 (fr) 2015-03-05
AU2019268049A1 (en) 2019-12-05
JP2016528302A (ja) 2016-09-15
AU2014314231A1 (en) 2016-03-03
US20180092875A1 (en) 2018-04-05
EP3038606A1 (fr) 2016-07-06
US20190125711A1 (en) 2019-05-02
AU2019268052B2 (en) 2021-09-02
EP3517102A1 (fr) 2019-07-31
US20220168255A1 (en) 2022-06-02
WO2015028473A1 (fr) 2015-03-05
US20180256530A1 (en) 2018-09-13

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Legal Events

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EEER Examination request

Effective date: 20190826

EEER Examination request

Effective date: 20190826

EEER Examination request

Effective date: 20190826

FZDE Discontinued

Effective date: 20230531